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Letairis Approval History

FDA Approved: Yes (First approved June 15, 2007)
Brand name: Letairis
Generic name: ambrisentan
Dosage form: Tablets
Company: Gilead Sciences, Inc.
Treatment for: Pulmonary Hypertension

Letairis (ambrisentan) is an endothelin receptor antagonist (ERA) indicated for the once-daily oral treatment of pulmonary arterial hypertension.

Development History and FDA Approval Process for Letairis

DateArticle
Oct  2, 2015Approval FDA Approves New Treatment Combination of Gilead’s Letairis with Tadalafil for Pulmonary Arterial Hypertension (WHO Group 1)
Jun 18, 2007Approval U.S. Food and Drug Administration Approves Gilead's Letairis (ambrisentan) 5 mg and 10 mg Tablets for the Once-Daily Treatment of Pulmonary Arterial Hypertension (WHO Group 1) in Patients with WHO Functional Class II or III Symptoms
Feb 16, 2007Gilead's New Drug Application for Ambrisentan Receives Priority Review Status
Dec 19, 2006Gilead Submits NDA To U.S. FDA for Ambrisentan for the Treatment of Pulmonary Arterial Hypertension

Further information

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